11 - 15 years experience •

The Executive Director of Quality Assurance (Global GXP) has overall strategic and functional responsibility for quality assurance, quality systems, and oversight and reportingon global corporate GXP compliance. This position reportsto the Sr. Vice President, Technical Operations. It is a full-time position requiring a broad range of QA experience in GMP, GCP, GPvP, and GLP workingwithinternal collaborators and external vendors. This position also collaborates withinternal, non-GXP functions (e.g. Legal, HR, Finance, IT) in the execution of QA department activities and ensuring alignment where GXP and non-GXP systems meet. This position requires knowledge of global applicable regulations as well as industry and company GXP standards and procedures. The individual in this position is responsible for leading the QA team, which develops, applies, and maintains quality standards for the company and its vendors for adherence to applicable regulations/standards. This position develops inspection readiness strategies and leads inspection readiness projects. It requires domestic and some international travel.

ESSENTIAL FUNCTIONS:

The main strategic responsibilities are as follows:• Guide and oversee Intercept quality during development (Phase 1 to 3) and commercial (post-marketing, Phase 4) activities.• Provide interpretation of regulatory guidance documents, regulations, and directives and advice on applicability on internal programs and external vendors.• Oversee compliance and identify/minimize regulatory risks across disciplines (GCP, GVP, GMP and GLP).

• Bachelor’s degree in Organic chemistry, Biochemistry, or a relevant science; graduatedegreepreferred.• 10+ years of QA experience in the pharmaceutical or a related FDA/EU regulated industry required.• GCP and GMP QA experience are both requiredto be successful in this role.